FDA.reportPublic FDA data

Ixiaro

Manufacturer
Vetter Pharma Fertigung GmbH & Co. KG | Valneva Scotland | Vetter Pharma Fertigung GmbH & Co. KG (Mooswiesen) | Vetter Pharma Fertigung GmbH & Co. KG (Schuetzenstrasse) | Vetter Pharma Fertigung GmbH & Co. KG (Helmut-Vetter-Strasse) | Vetter Pharma Fertigung GmbH & Co. KG (Eisenbahnstrasse)
Effective date
2025-11-25
Label type
VACCINE LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:52:08

Label at a glance#

ProductIxiaro
Active ingredientJAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)
Label structure1 sections

Label contents#

Full prescribing information#

Valneva Ixiaro (JEV), Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55005511_JEV55005511_JEV

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1300783IXIARO 6 MCG in 0.5 ML Prefilled SyringePSN10
1300781Japanese encephalitis vaccine 6 MCG in 0.5 ML Prefilled SyringePSN10
13007830.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe [Ixiaro]SBD10
13007810.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled SyringeSCD10
13007830.5 ML Ixiaro 0.012 MG/ML Prefilled SyringeSY10
1300783Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) 0.012 MG/ML 0.5 ML Prefilled SyringeSY10
1300783Ixiaro 6 MCG per 0.5 ML Prefilled SyringeSY10
1300781Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 6 MCG per 0.5 ML Prefilled SyringeSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128100007560388VK1_55005511_JEV.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62195-051-01Ixiaro0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.510

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62195-05162195-051-01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125280IxiaroJapanese Encephalitis Vaccine, Inactivated, Adsorbed351(a)Rx2026-09-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED)DZ854I04ZEACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.